Pacemaker and ICD generator malfunctions: Analysis of Food and Drug Administration annual reports

Article Abstract:

The postapproval annual reports submitted to the US Food and Drug Administration (FDA) by manufacturers of pacemakers and implantable cardioverter-defibrillators (ICDs) is analyzed to determine the reported number and rate of pacemaker and ICD malfunctions. Although pacemakers and ICDs are important life-sustaining devices that have saved many lives, careful monitoring of device performance is still required.

Product information, Testing, United States. Food and Drug Administration

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Pacemaker and ICD malfunction: An incomplete picture

Article Abstract:

Pacemakers and (ICDs) are dependent on the entire implanted system to function properly where the device, the leads, the chosen programmed parameters, and the patient's response are all interdependent. The system malfunction rate may be the most important measure of reliability, but it is also the most elusive because no single measure captures all elements in a verifiable fashion.

Evaluation

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